510(k) K241372

Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ by Abbott Medical — Product Code MTD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2024
Date Received
May 15, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intracardiac Mapping, High-Density Array
Device Class
Class II
Regulation Number
870.1220
Review Panel
CV
Submission Type